Pulmonary Embolism: an Autopsy Study

NCT03887819 | Completed

• 1 other identifier: SecondUNI 21.03.2019
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND: Pulmonary embolism (PE) is associated to high mortality rate worldwide. However, the diagnosis of PE often results inaccurate. Many cases of PE are incorrectly diagnosed or missed and they are often associated to sudden unexpected death (SUD). In forensic practice, it is important to establish the time of thrombus formation in order to determine the precise moment of death. The autopsy remains the gold standard method for the identification of death cause allowing the determination of discrepancies between clinical and autopsy diagnoses. The aim of our study will be to verify the morphological and histological criteria of fatal cases of PE and evaluate the dating of thrombus formation considering 5 ranges of time. METHODS: Pulmonary vessels sections will be collected from January 2010 to December 2017. Sections of thrombus sampling will be stained with hematoxylin and eosin. The content of infiltrated cells, fibroblasts and collagen fibers will be scored using a semi-quantitative three-point scale of range values. Hypothesis: After a macroscopic observation and a good sampling traditional histology, it will be important to identify the time of thrombus formation. We will identify histologically a range of time in the physiopathology of the thrombus (early, recent, recent-medium, medium, old), allowing to determine the dating of thrombus formation and the exact time of death.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• To evaluate pulmonary thrombus burden

  Authors will evaluate if a pulmonary embolus was originated prior or subsequent to a traumatic event. However, they will evaluate the dimension of the thrombus, and the quantity of fibrinogen present in the thrombus, from pulmonary vessels sections. The tissues samples will be fixed in 10% neutral buffered formalin and embedded in paraffin blocks, and stained with hematoxylin and eosin stain for diagnosis. For inflammatory cellular infiltration and fibrosis, authors will attribute a score 0 for no increase, score 1, 2, or 3 for little, moderate, or high increase of cell content compared to adjacent tissue, respectively. For the extracellular matrix production, authors will attribute a score 0 for absence of collagen production, score 1 and 2 for 10-40% and 40-80% collagen fibers content compared to adjacent normal tissue, respectively, and finally score 3 for wound matrix indistinguishable from adjacent normal tissue.

  24 months

Interventions

Hystological evaluation DIAGNOSTIC_TEST

The original tissues samples will be fixed in 10% neutral buffered formalin and embedded in paraffin blocks. Sections (4 μm thick) will be stained with hematoxylin and eosin stain (H\&E) for diagnosis. The immunohistochemistry for anti-LCA, anti-CD68, and anti-CD3 will be performed to identify the inflammatory infiltrate.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include 19 male (63.3%) and 11 female (36.7%). Their age will range from 38 to 87 years.

You may qualify if:

• diagnosis of acute pulmonary embolism;
• patients died after the pulmonary embolic event.

You may not qualify if:

• diagnosis of non acute pulmonary embolism;
• patients survived after the pulmonary embolic event.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Related Publications (1)

• Mansueto G, Costa D, Capasso E, Varavallo F, Brunitto G, Caserta R, Esposito S, Niola M, Sardu C, Marfella R, Napoli C, Paternoster M. The dating of thrombus organization in cases of pulmonary embolism: an autopsy study. BMC Cardiovasc Disord. 2019 Nov 8;19(1):250. doi: 10.1186/s12872-019-1219-8.

  PMID: 31703628 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

human tissue samples and pulmonary thrombi.

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: January 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03